Phase 4
N=20
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
Ovarian Cancer · Uterine Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01432015 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Overall Complete Response Rate — 10; 10 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fosaprepitant (Drug); aprepitant (Drug); Oral Placebo (Other); IV placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Associates
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Complete Response Rate |
10; 10 | — |
| SECONDARY Impact on Daily Living Activities |
10; 10 | — |
Summary
Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.
Eligibility Criteria
Inclusion Criteria
- Female Gender
- Age > 18 years
- A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian, fallopian tube, peritoneal cancer and uterine cancer).
- Subjects who will be treated with Taxol and Carboplatin as standard of care for a newly diagnosed gynecological cancer.
- Adequate bone marrow function as demonstrated by:
Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9 g/dL • Adequate renal function demonstrated by: Serum creatinine of 60 mL/min for patients with serum creatinine > 1.5 x ULN
- Adequate hepatic function demonstrated by: Total bilirubin of 2
- Gastrointestinal obstruction or an active peptic ulcer
- Patients who are pregnant or breast feeding because aprepitant may be harmful to the developing fetus and newborn
- Known active HIV and viral hepatitis infections
- Inability to comply with study
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
Data sourced from ClinicalTrials.gov (NCT01432015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.